CYPHER ® Clinical Evidence in Acute Myocardial Infarction (AMI)

CYPHER® Clinical Evidence in Acute Myocardial Infarction (AMI)

The Development of AMI

UnstableAngina

AtheroscleroticPlaque

PlaqueRupture

Spontaneous orPost-Intervention

AcuteMyocardial Infarction

Plaque is subjected to erosion

and/or disruption

Lipid-rich core exposed after rupture

is highly thrombogenic

• Causes platelet activation

• Elicits the coagulation cascade

Thrombus formation

• Sub-occlusive - unstable angina

• Occlusive - AMI

A pro-inflammatory environment

The Value of a Sirolimus-eluting Stent in AMI

Inflammatory cytokine levels are high in AMI

Neointimal hyperplasia following bare-metal stent implantation is an inflammatory response

CYPHER® Stent has been proven to significantly inhibit:• Strut-associated inflammation1

• Neointimal hyperplasia1

1. Suzuki T, et al. Circulation. 2001;104:1188-93.

Randomised Trials in AMI Show a Clinical Advantage for

CYPHER® Stent vs BMS

Superiority of CYPHER® Stent in AMI: Randomised Controlled Trials

1. Valgimigli M, et al. JAMA. 2005;293(17):2109-17. 2. Spaulding C, et al. N Engl J Med. 2006;355(11):1093-104. 3. Menichelli M, et al. J Am Coll Cardiol. 2007;49(19):1924-30. 4. Di Lorenzo E, et al. ACC Scientific Sessions 2005. Presentation 2303. 5. Pittl C, et al. Eur Heart J. 2006;27:650 (abstract suppl). 6. van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26. 5. Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32. 7. Diaz L, et al. Am Heart J. 2007;154(1):164.e1 – 164.e6. 9. Valgimigli M, et al. JAMA 2008;299(15):1788-99.

Study Comparator Stent

Number of Patients

Late Loss in-stent (mm)

Binary restenosisIn-stent (%)

TLR (%) MACE (%)

STRATEGY1 BMS 175 CYPHER®: -0.22BMS: 0.6

CYPHER®: 7.5BMS: 28

CYPHER®: 6 BMS: 20

CYPHER®: 18 BMS: 32

TYPHOON2 BMS 721 CYPHER®: 0.14BMS: 0.83

CYPHER®: 3.5BMS: 20.3

CYPHER®: 3.7 BMS: 12.6

-

SESAMI3 BMS 320 CYPHER®: 0.18 BMS: 0.85

CYPHER®: 9.3BMS: 21.3



DI LORENZO4 BMS/Taxus 180 - -CYPHER®: 0.0

Taxus: 1.5 BMS: 15.6

CYPHER®: 6.4 Taxus: 8.1 BMS: 23.6

BASKET-AMI5 BMS 217 - -DES: 4.9

BMS: 8.1 (TVR)DES 7.6

BMS: 16.7

MISSION!6 BMS 310 CYPHER®: 0.19 BMS: 0.95



CYPHER®: 13.9 BMS: 26.3

DIAZ7 BMS 120 - - CYPHER®: 0.0 BMS: 5.7 (TVF)


PROSIT8 Taxus 308 CYPHER®: 0.19 Taxus: 0.43

CYPHER®: 5.0 Taxus : 12.0



MULTISTRATEGY9 BMS 745 - - CYPHER®: 3.2 BMS: 10.2


TYPHOONStudy Design

Randomisation 1:1

Any Bare-Metal Stent(357 patients)

CYPHER® or CYPHER Select®

Sirolimus-eluting Stent(355 patients)

Patients Presenting within 12 hours after Onset of Symptomsof a First AMI Requiring Primary PCI of a Native Coronary Artery

Primary Endpoint: Target Vessel Failure (TVF) at 1 YearDefined as composite of ischaemia-driven Target Vessel Revascularization (TVR),

recurrent Myocardial Infarction (MI), or Target Vessel-related Cardiac Death

Angiographic Substudy (200 pts): In-stent Late Loss at 8-Months

Dual APT recommended for 6 months (Clopidogrel: ~ 75% at 6 months and ~ 50% at 12 months)

Spaulding C, et al. N Engl J Med. 2006;355:1093-104.

TYPHOONLower TVF Risk vs BMS

25

20

10

5

0

Pa

tie

nts

(%

)

15

0

60 120 180 240 300 360Time (days)

3.14.2

7.3

2.8

6.2

14.3

49%p=0.0036*

CYPHER® BMS

1º Endpoint: TVF at 1 year*

* Defined as ischaemia driven TVR, recurrent MI, or target vessel-related cardiac death


Intention-to-Treat Analysis at 1 year

0

5

10

15

20

25

6.8

12.7

N=251N=251

P = 0.034

TYPHOONSignificant Benefit without Angiographic F/U

Spaulding C, et al. PCR 2006

TVF: Intention-to-Treat Analysis at 1 year

CYPHER© BMS

TYPHOONSuperior Clinical Outcomes vs BMS

30

Pa

tie

nts

(%

)

25

15

10

5

20

0

Death

2.3 2.2

p=NS

MI

1.1 1.4

p=NS

TVR

5.6

13.4

p<0.001

TVF*

7.3

14.3

PrimaryEndpoint

p=0.004

Intention-to-Treat Analysis at 1 year

* Defined as ischaemia-driven TVR, recurrent MI, or target vessel-related cardiac death


CYPHER® BMS

Diaz de la LleraStudy Design

Randomisation 1:1

BMSplus abciximab

(60 patients)

CYPHER® Stentplus abciximab

(60 patients)

Consecutive patients with STEMI over the age of 18 years

Primary Endpoint: Composite of death, non-fatal MI and recurrent myocardial ischaemia within 360 days after initial procedure

Diaz de la Llera LS, et al. Am Heart J. 2007;154:164.e.1-6.

Diaz de la LleraBetter Event-Free Survival vs BMS at 1 year

1.0

0.8

0.7

Ev

en

t-fr

ee

su

rviv

al

(%)

0.9

360300240180120600

CYPHER© stent 0.0% BMS 5.7%p=0.064

CYPHER© Bare Metal Stents

Days after initial procedure

Secondary endpointSurvival free from TVF

Primary endpoint*Event-free survival at 360 days

93.3

88.9

RR=1.75 (95% CI; 0.47 – 6.57)p=0.402

*Defined as composite of death, non-fatal MI and recurrent myocardial ischaemia within 360 days after initial procedure

Diaz de la Llera LS, et al. Am Heart J. 2007;154:164.e.1-6.

MISSION!Study Design

Randomisation 1:1

Vision BMS (152 patients)

CYPHER® Stent(158 patients)

Patients with ECG-demonstrated STEMI with symptoms <9h before procedure

Primary Endpoint: In-segment late-lumen loss at 9 months

Refvan der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26.

MISSION!Lower Late Loss vs BMS

CYPHER® Stent 37.5%BMS 12.5%p < 0.001

An

gio

gra

ph

ic i

n-s

eg

me

nt

late

lo

ss

(m

m)

0.5

0.3

0.2

0.1

0.4

0

CYPHER© BMS

0.6

0.7

0.8

p<0.001

0.12

0.68

Primary endpointIn-segment late loss (9 months)

Secondary endpointLate stent malapposition at any site

(9 months)

Secondary endpointEvent- free survival (12 months)

CYPHER® Stent 86.0%BMS 73.6%p = 0.01

van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26.

MULTISTRATEGYStudy Design

CYPHER® Stentplus abciximab

(186 patients)

Patients with (1) chest pain > 30 mins with an ECG ST-segment elevation of 1 mm 2 or more leads, or with a new left bundle-branch block,and (2) admission within 12 h of symptom onset or 12-24 hours

after onset with evidence of continuing ischaemia

Primary Endpoint (drug comparison): 50% recovery at 90 minutes Primary Endpoint (stent comparison): MACE at 8 months

CYPHER® Stentplus tirofiban(186 patients)

BMSplus abciximab

(186 patients)

BMSplus tirofiban(186 patients)

Randomisation 1:1:1:1

Valgimigli M, et al. JAMA. 2008;299(15):1788-99.

MULTISTRATEGYLower MACE* Rates vs BMS

20

10

5

0

15

60 100

160

180

200

260Days after randomisation

7.8%

14.5%

20 40 80 120

220

240

140

CYPHER® BMS

Uncoated Stent 372 351 342 326 318

CYPHER Stent 372 355 351 347 343

MA

CE

* (%

)

No. at risk

Adjusted HR: 0.53 (97.5% CI: 0.33-0.83); p=0.006p=0.0039 at Log-rank test

0

Valgimigli M, et al. JAMA. 2008;299(15):1788-99.

No prespecified angiographic F/U

Broad inclusion criteria

Dual APT recommended for ≥ 3 months(Clopidogrel: ~ 90% at 1 month and ~ 20% at 8 months)

*Death, MI, or TVR

CYPHER® Stent vs BMS: No difference in Stent Thrombosis Summary of CYPHER® Stent vs BMS Trials

Pa

tie

nts

(%

)

10

6

4

2

MULTISTRATEGY

2.7

8-month

Diaz

3.4

1.8

MISSION

1.32.0

TYPHOON

3.4 3.6

SESAMI

4.7

6.0

STRATEGY

1.2

4.6

8

0

1-year 1-year 1-year 2-year 2-year

4.0

Definitions of ST vary by trial: ARC Def/Probable used when possible

Dual APTRecommendation

n=745

3 months

n=120

9 months

n=308

12 months

n=712

6 months

n=320

12 months

n=175

6 months

p=NS for all trialsCYPHER® BMS

Randomised Trials in AMI Show a Clinical Advantage for

CYPHER® Stent vs Taxus®

Taxus in AMIPASSION Study Design

Randomisation 1:1

BMS(n=310)

Taxus Express2 or Liberte Stent(n=309)

STEMI patients with chest pain > 20mn and ST-elevation in ≥2 contiguous leads; infarct related artery with a de novo lesion

Primary Endpoint: Composite of death, recurrent MI, or target lesion (within 5 mm of stent edges) revascularization (TLR) at one year

Laarman, GJ et al. N Engl J Med. 2006;355:1105-13.

Not all DES are created equal: PASSION Primary Endpoint* at 1 Year Follow-up Not Met

MA

CE

(%

)

10

0 120 240 360

5

0

Taxus BMS

Laarman, GJ et al. N Engl J Med. 2006;355:1105-13.

Days

PRIMARY ENDPOINT NOT ACHIEVEDHR=0.68 (0.41-1.10)

p=0.12

8.7

12.6No prespecified angiographic F/U

Dual APT recommended for ≥ 6 months (Clopidogrel: Median Duration of 9 months)

*Cardiac Death, MI, or TLR

Not all DES are created equal: PASSION 2-Year Outcomes

p =0.12

p =0.32

p=0.09

OR 0.70 (95% CI: 0.45-1.09)

OR 0.78 (95% CI: 0.41-1.44)

OR 0.60(95% CI: 0.34-1.09)

Dirksen MT. Presented at ESC 2007.

15.4

7.2

9.911.1

5.6 6.0

0

5

10

15

20

MACE Cardiac Death TLR

% o

f P

ati

en

ts

Taxus BMS

PROSITStudy Design

Acute STEMI 12 hrs or persistent ischaemia 12-24 hrs (n = 231)

Randomisation 1:1

CYPHER®

(n=116)

Taxus(n=115)

Primary Endpoint: In-segment late loss at 6 months

Secondary Endpoints: MACE at 30 days and 9 months andangiographic in-segment restenosis at 6 months

Lee JH, et al. Catheter Cardiovasc Interv. 2008;72(1):25-32.

PROSITSuperior Angiographic Outcomes vs Taxus

CYPHER© Taxus

In-segment Late Loss(6 months)

p=0.002

0.33

La

te L

os

s (

mm

)

0.3

0.2

0.1

0

0.09

0.4

0.5

In-segmentCYPHER® 5.9%Taxus 14.8%p= 0.03

In-stentCYPHER® 5.0%Taxus 12.0%p= 0.09


Other endpointsAngiographic binary restenosis

(6 months)

PROSITImproved Clinical Outcome (MACE & TLR) vs Taxus

CYPHER© Taxus

MACE(12 months)

P=0.07

11.7

Pa

tie

nts

(%

)

15

10

5

0

5.8

20

TLR(12 months)

P=0.17

6.5

Pa

tie

nts

(%

)

7.5

5

2.5

0

2.6

10


Meta-analyses Confirm the Value of DES in AMI

Meta-analysis of DES trials in AMI DES vs BMS in STEMI Patients1

Study No. of patients

Mean age (years)

Typeof DES Primary endpoint

Length of thienopyridine

therapy (months)

Mean length of follow-up (months)

BASKET-AMI2 216 62.2 PESSES

Cardiac death, myocardial infarction, or reintervention 6 18.0

Di Lorenzo3 270 64.0 PESSES

Death, myocardial infarction, or reintervention 6 12.0

HAAMU-STENT4 164 63.0 PES Angiographic late lumen loss 12 16.7

MISSION5 310 59.2 SES Angiographic late lumen loss 12 12.0

PASSION6 619 60.8 PES Cardiac death, myocardial infarction, or reintervention 6 12.0

SESAMI7 320 61.6 SES Angiographic binary restenosis 12 12.3

STRATEGY8 175 62.6 SESDeath, myocardial infarction,

stroke, or angiographic binary restenosis

3 24.2

TYPHOON9 712 59.3 SES Cardiac death, myocardial infarction, or reintervention 6 12.1

1. Kastrati A, et al. Eur Heart J. 2007;28:2706-2713. 2. Pittl C, et al. Eur Heart J. 2006;27:650 (abstract suppl). 3. Di Lorenzo E, et al. ACC Scientific Sessions 2005. Presentation 2303. 4. HAAMU-STENT trial. Available at wwwcardiosourcecom/pops/trialSumasp?trialID=1492. Accessed 5 March 2007. 5. van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26. 6. Laarman GJ et al. N Engl J Med. 2006; 355:1105-13. 7. Menichelli M, et al. J Am Coll Cardiol. 2007;49(19):1924-30. 8. Valgimigli M, et al. JAMA. 2005;293(17):2109-17. 9. Spaulding C, et al. N Engl J Med. 2006;355(11):1093-104.

Meta-analysis of DES trials in AMI*Lower Rate of Reintervention with DES

20

10

5

Pro

ba

bil

ity

of

rein

terv

en

tio

n (

%)

15

0

11 12Months after randomization

109876543210

2786 patients

DES BMS

HR: 0.38 (95% CI, 0.29–0.50)p< 0.001

*Trials included were:BASKET; di Lorenzo; HAAMU-STENT; MISSION;

PASSION; SESAMI; STRATEGY; TYPHOON Kastrati A, et al. Eur Heart J. 2007;28:2706-2713.

Meta-analysis of DES trials in AMI*Similar Low Rates of Death, Recurrent MI

10

Pro

ba

bil

ity

of

de

ath

(%

) 8

4

6

2

0

HR: 0.76 (95% CI, 0.53-1.10)p=0.14

Months after randomisation0 1 2 3 4 5 6 7 8 9 10 11 12

10

8

4

6

2

0

HR: 0.72 (95% CI, 0.48-1.08)p=0.11

Months after randomisation0 1 2 3 4 5 6 7 8 9 10 11 12

Pro

ba

bil

ity

of

rec

urr

en

tm

yo

ca

rdia

l in

farc

tio

n (

%)


PASSION; SESAMI; STRATEGY; TYPHOON

DES BMSDES BMS

Kastrati A, et al. Eur Heart J. 2007;28:2706-2713.

Meta-analysis of DES trials in AMI*Similar Low Rates of Stent Thrombosis

5

4

2

1

0

Pro

ba

bil

ity

of

ste

nt

thro

mb

os

is (

%)

3

0

1 2 4 8 11 12Months after randomisation

DES BMS

106 9753

2786 patients


PASSION; SESAMI; STRATEGY; TYPHOON

HR: 0.80 (95% CI, 0.46-1.39)p=0.43

Kastrati A, et al. Eur Heart J 2007;28:2706-2713.

Long-term RCT Data Support the Use of

CYPHER® Stent in AMI

SESAMIStudy Design

Randomisation

CYPHER®

(n=160)

BMS(n=160)

Primary Endpoint: binary restenosis at the 1-year angiographic follow-up

Secondary Endpoints: TLR, TVR, MACE and TVF at 1 year

Menichelli M, et al. J Am Coll Cardiol 2007;49:1924-1930.

Patients >18 years, with symptoms of acute MI for ≥30min but ≤12h and had ≥1mm ST-segment elevation in at least 2 contiguous leads or left bundle-

branch block (n=320)

SESAMI at 2 yearsSignificantly Lower TLR and TVR Rates vs BMS

Pa

tie

nts

(%

) 10

6

4

2

TLR TVR

8

0

CYPHER® BMS

12

14

16

p<0.05

Menichelli M, et al. SESAMI 2 year results. Presented at TCT 2007.

p=0.022

12.7

8.7

6.0

14.0

17

SESAMI at 2 yearsLower Death and Re-AMI rates vs BMS

Pa

tie

nts

(%

)

10

6

4

2

Death Re-AMI

8

0

CYPHER® BMS

Menichelli M, et al. SESAMI 2 year results. Presented at TCT 2007.

8.0

2.7

4.73.3

Stent Thrombosis *

*ARC definitions (Definite/Probable)

4.7

6.0

STRATEGYStudy Design

Randomisation 1:1

tirofiban plusCYPHER®

(n=87)

abciximab plusBMS

(n=88)

Primary Endpoint: Freedom, at 8 months after randomisation, from death, non-fatal MI, stroke and binary restenosis

Secondary Endpoints: Freedom, at day 30 and month 8, from major cardiac or cerebrovascular adverse events defined as the composite of death, reinfarction ,

stroke and repeat TVR

Valgimigli M, et al. JAMA 2005;293(17):2109-2117

Inclusion Criteria: STEMI(n = 175)

50

40

20

10

0

30

0

200 400 600 1000 14001200800

BMS = bare metal stent, CI = confidence interval, SES = sirolimus-eluting stent, TVR = target vessel revascularization

STRATEGYLower 3-Year MACE rates vs BMS

Pro

ba

bil

ity

of

Ev

en

ts(%

)

Days after Randomization

tirofiban + SESabciximab + BMS

Hazard Ratio 0.64[95% CI: 0.39-1.07]; p=0.089

41%

29%

50

40

20

10

0

30

0

200 400 600 1000 14001200800

BMS = bare metal stent, SES = sirolimus-eluting stent

STRATEGYSimilar Low Rates of Death and MI at 3 Years

Pro

ba

bil

ity

of

Ev

en

ts(%

)



P=0.57 at log rank test5

15

25

35

45

23%20%

50

40

20

10

0

30

0

200 400 600 1000 14001200800

BMS = bare metal stent, SES = sirolimus-eluting stent.

STRATEGYSimilar Low Rates of Stent Thrombosis at 3 Years

Pro

ba

bil

ity

of

Ste

nt

Th

rom

bo

sis

(AR

C c

las

sif

ica

tio

n)



P=0.76

6.8%5.7%

TYPHOONStudy Design

Randomisation 1:1

Any Bare-Metal Stent(357 patients)

CYPHER® or CYPHER Select®

Sirolimus-eluting Stent(355 patients)

Patients Presenting within 12 hours after Onset of Symptomsof a First AMI Requiring Primary PCI of a Native Coronary Artery

Primary Endpoint: Target Vessel Failure (TVF) at 1 YearDefined as composite of ischaemia-driven Target Vessel Revascularization (TVR),

recurrent Myocardial Infarction (MI), or Target Vessel-related Cardiac Death

Angiographic Substudy (200 pts): In-stent Late Loss at 8-Months

Dual APT recommended for 6 months (Clopidogrel: ~ 75% at 6 months and ~ 50% at 12 months)


TYPHOONDeath and MI at 3 Year Follow-up

100

90

80

95

85

p=0.69

CYPHER®

Death

BMS

Time (days from initial procedure)

Fre

ed

om

of

ev

en

ts (

%)

100

90

80

95

85

p=0.99

CYPHER® BMS

Time (days from initial procedure)

Fre

ed

om

of

ev

en

ts (

%)

Q and non-Q MI

Non adjudicated events

Error bars indicate a point-wise two-sided 95% confidence interval (1.98 + stand. err.)Standard Error based on the Greenwood Formula


0 180 360 540 720 900 1080 0 180 360 540 720 900 1080

Spaulding C, presented at EuroPCR 2008.

TYPHOONFreedom from Revascularisation at 3 Year Follow-up

Non adjudicated events

100

80

70

0

Fre

ed

om

of

ev

en

ts (

%)

90

60

120 200 300 540 900 1,080Time (days from initial procedure)

p=0.045

BMSCYPHER®

680420

65

75

85

95


60 180 240 360 480 600 720 780 960 1,020

Revascularisation (PCI, CABG, TVR and non-TVR)


Long-term Registries Data Support the Use of

the CYPHER® Stent in AMI

Summary of DES vs. BMS STEMI Registries with Long-term Follow-up

2-year New Jersey State Registry (MIDAS)n = 5,174

Mortality Significantly Favours DES0.60 (0.50-0.73)

2-year Massachusetts

n = 2,629

Mortality Significantly Favours DESp=0.002; -2.7% [-4.5%, 0%]

2-year GRACE

n = 2,298

Mortality Significantly Favours BMS8.6% DES vs. 1.6% BMS; p< 0.001

3-year RESEARCH

n = 369

No Difference in Mortality11.5% vs. 13.3%; p=NS

3-year Minnesota Heart

n=858

Significant Difference Favouring SES and PES vs. BMS

in freedom from mortality

4-yearNakamuran = 1,542

No significant differences in mortality between DES and BMS

MIDAS NJ State Registry2-Year Mortality and CV Mortality

AMI Setting DES BMS All Cause Mortality DES BMS CVD Death

STEMI 141(n=2,217)

323(n=2,957)

0.60 (0.50-0.73)

88(n=2,217)

191(n=2,957)

0.67(0.52-0.86)

Cox Adjusted Hazard Ratios for 2-Year All-Cause and CV Mortality Comparing STEMI Patients with DES to BMS

N-values refer to number of patients at baseline

Vagonescu T, et al. MIDAS Registry. Presented at TCT 2007.

Massachusetts State Registry 2-Year Outcome in Matched MI Patients

BMS DES

Time after initial procedure (days)

Cu

mu

lati

ve

in

cid

en

ce

(%)

Death

0 180 365 730

30

20

10

030

DES 2,629 2,618 2,550 2,484 2,433

No. at risk

BMS 2,629 2,614 2,512 2,431 2,373

DES 2,629 2,624 2,427 2,243 2,127

No. at risk

BMS 2,629 2,618 2,372 2,091 1,957

Cu

mu

lati

ve

in

cid

en

ce

(%)

Revascularisation

0 180 365 730

30

20

10

030


BMS DES


Cu

mu

lati

ve

in

cid

en

ce

(%)

Recurrent MI

0 180 365 730

30

20

10

030

DES 2,629 2,604 2,483 2,368 2,263

No. at risk

BMS 2,629 2,592 2,430 2,285 2,192

DES 2,629 2,624 2,492 2,380 2,291

No. at risk

BMS 2,629 2,618 2,443 2,250 2,148

Cu

mu

lati

ve

in

cid

en

ce

(%)

TVR

0 180 365 730

30

20

10

030


Mauri L, et al. Presented at ACC 2008.

GRACE Registry 2-Year Mortality

Steg PG, et al. Presented at ESC 2007

Pa

tie

nts

(%

)

p<0.0001

15

10

5

STEMI

1.6

NST EMI/UA

3.92.9

20

0

8.6

DESBMS

p=0.5

n=1,729 n=569 n=569 n=1,729

*2-year GRACE: note this registry has incomplete follow-up, baseline characteristics were not equal between groups, inclusion criteria are not known and is currently unpublished data

RESEARCH3-Year Mortality

Daemen J, et al. Am J Cardiol. 2007;99:1027-32.

Pa

tie

nts

(%

)

15

10

5

RESEARCH

11.512.4

20

0

13.3

n=183 n=186 n=136

p=NS for all

3-year Registry

SES BMS PES

Minnesota Heart Experience

3-Year Mortality

Henry T, et al. FDA Panel (FDA.gov). Minnesota Heart Experience

Up to 3-years Registry

Log-rank test:Overall: p < 0.0001BMS vs. SES: p < 0.0001BMS vs. PES: p = 0.002SES vs. PES: p = 0.1924S

urv

iva

l p

rob

ab

ilit

y

0.8

0.6

0.2

1.0

0

0.4

0 200 400 600 800 1000 1200

SES

BMS

PES

Nakamura4-year Event-free Survival from MACE*

100

60

40

20

0

80

0

Time (months) 6 1

218

24

30

36

42

48

p<0.0001

Nakamura. Presented at ACC 2007 (i2 Summit).

SES BMS PES

STEMI Patients

*Death, MI, CABG, TVR, TVF

CYPHER® Stent in AMIConclusions

DES During Primary PCI for AMI

Primary PCI for AMI saves lives

Recommendations: • Reduce door to balloon delays

• Proper pharmacological regimen

• Perform thromboaspiration

• Inject nitrates and assess the size of the artery

“Best candidate” for DES in AMI:• early onset

• high risk of restenosis

• after thromboaspiration and pre-dilatation

• DES if patient’s compliance for double antiplatelet therapy is assured

Spaulding C. Presented at EuroPCR 2008

Impact of Thrombus Burden on Mortalityafter use of DES in STEMI

25

Cu

mu

lati

ve m

ort

alit

y (%

)

15

10

5

0

9.8%

p=0.076

20

0

Follow-up (months)

1 3 6 9 12

15

18

21

24

p=0.074p=0.025p=0.048

6.2%

11.6%

7.2%

12.9%

7.8%

12.9%

9.4%

Large thrombus burden Small thrombus burden

Sianos G, et al. JACC 2007;50:573-83.

CYPHER® Stent in AMI

Lesion site following plaque rupture is highly pro-inflammatory

The CYPHER® Sirolimus-eluting Stent is proven to reduce inflammation and neointimal hyperplasia

RCTs in AMI show that CYPHER® Stent significantly reduces:• Reintervention risk

• Major adverse coronary events

CYPHER® Select Plus Stent obtained CE Mark for the treatment of AMI in July 2008

CYPHER ® Clinical Evidence in Acute Myocardial Infarction (AMI)

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